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NCT04467008 Clinical Trial

Covid-19 Rapid Diagnostic Tests on Blood Drop

Covid19 Clinical Trial

— COVID-TEST  

Official title:
Evaluation of Covid-19 Rapid Diagnostic Tests on Blood Drop

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04467008
Other study ID # 2020/05
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 15, 2020
Est. completion date August 15, 2020

Study information
Verified date July 2020
Source CMC Ambroise Paré
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will evaluate the diagnostic reliability of the Biosynex rapid blood test for Covid-19 infection.

Description:

The Covid-19 pandemic requires a reliable diagnosis of affected patients in order to manage them in an appropriate manner, in the appropriate departments. Furthermore, the diagnostic reference at the time of this study is based on reverse transcription by reaction in polymerase chain reaction (RT-PCR) on a nasopharyngeal swab taken. This method has may yield false negatives (up to 30% depending on the series) and its lead time is several hours. Alternatives are therefore being developed, in particular rapid blood tests. The rapid diagnostic test distributed by Biosynex has been evaluated by the National Reference Center for Respiratory Infections Viruses as very specific for the detection of IgG + IgM (93%). As part of the evaluation of this test, it was used in patients with severe Covid-19 disease, requiring hospitalization in critical care in order to be able to establish their reliability in a clinical context where many confounding factors may occur, such as lymphopenia or systemic inflammation. However, the early diagnosis of this patient population remains critical in order to be able to refer them to the appropriate services.

Recruitment information / eligibility
Status Completed
Enrollment 113
Est. completion date August 15, 2020
Est. primary completion date August 15, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Confirmed COVID-19 diagnosis with at least one positive RT-PCR Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CMC Ambroise Paré Neuilly-sur-Seine

Sponsors (1)
Lead Sponsor Collaborator
CMC Ambroise Paré

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Positivity of the rapid diagnostic test Positivity of the rapid diagnostic test, assessed by the presence of either IgM or IgG Immediate, up to 1 day.
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